By Fran DeGrazio, Executive Advisor, Kymanox Corporation
Materials used in a drug package or device design are fundamental to ensuring a safe and effective drug development program. The recent growth in complex therapeutics has increased demand for sophisticated packaging and device designs as these products are extremely sensitive to their environmental and storage conditions. Device developers need to understand material properties of the various components and how those properties may be affected when interacting with the drug or other materials in the system.
Manufacturers need to emphasize that all materials chosen to be used in a cell and gene therapy product should be backed by quantitative studies and data indicating that material properties are not adversely affected by extreme conditions or that changes to properties do not adversely affect the drug product. Explore considerations for the series of characterizations necessary to ensure the efficacy of a packaging or device component and final drug delivery system.